FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma
On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also granted Priority Review for the application, and the Prescription Drug User Fee Act (PDUFA) target action date is May 1, 2018.
The submission of the sBLA is based on positive results from the phase III ECHELON-1 trial, which sought to determine if brentuximab vedotin in combination with chemotherapy could extend modified progression-free survival in previously untreated advanced classical Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate directed to CD30, a defining marker of classical Hodgkin lymphoma.
“The FDA’s filing of our sBLA with Priority Review represents a significant milestone in our goal to redefine the frontline treatment of advanced Hodgkin lymphoma,” said Clay Siegall, PhD, President and Chief Executive Officer of Seattle Genetics. “We recently reported the primary data from the phase III ECHELON-1 clinical trial in the Plenary Scientific Session of the 2017 American Society of Hematology Annual Meeting [Abstract 6] with simultaneous publication in The New England Journal of Medicine. The data demonstrated superior activity of the brentuximab vedotin–containing regimen over standard of care, and we are working with the FDA to make this bleomycin-free regimen available to newly diagnosed advanced Hodgkin lymphoma patients as soon as possible.”
More on ECHELON-1
The ECHELON-1 study evaluated a combination of brentuximab vedotin plus AVD (doxorubicin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen, ABVD (which includes bleomycin), in front-line advanced classical Hodgkin lymphoma. Results from the ECHELON-1 trial in 1,334 Hodgkin lymphoma patients included:
- Reaching its primary endpoint, with the combination of brentuximab vedotin plus AVD resulting in a statistically significant improvement in modified progression-free survival vs the control arm of ABVD as assessed by an Independent Review Facility (P = .035). This corresponds to a 23% reduction in the risk of progression, death, or need for additional anticancer therapy. Per Independent Review Facility assessment, the 2-year modified progression-free survival rate for patients in the brentuximab vedotin–plus-AVD arm was 82.1% compared to 77.2% in the control arm.
- The investigator assessment of modified progression-free survival also demonstrated a statistically significant advantage for brentuximab vedotin plus AVD vs the control arm of ABVD (P < .01).
- All secondary endpoints, including interim analysis of overall survival, trended in favor of the brentuximab vedotin–plus-AVD arm.
The safety profile of brentuximab vedotin plus AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen.
In October 2017, the FDA also granted brentuximab vedotin Breakthrough Therapy designation based on the ECHELON-1 study results.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
